NCT07324980 Acute DYSPnea in the Emergency Department: Diagnostic Value of Point-of-care UltraSound
| NCT ID | NCT07324980 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Università degli Studi del Piemonte Orientale Amedeo Avogadro |
| Condition | Hydrostatic Pulmonary Edema |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-11-01 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Acute dyspnea is a common reason for emergency department (ED) admission and is frequently caused by acute heart failure with pulmonary edema. Rapid differentiation between cardiogenic and non-cardiogenic causes of dyspnea is essential to guide early treatment and risk stratification. However, no single gold standard exists for the assessment of venous congestion in the acute setting. This prospective observational study aims to evaluate the diagnostic accuracy of respiratory variation in inferior vena cava (IVC) diameter measured by point-of-care ultrasound (POCUS) in identifying acute pulmonary edema in patients presenting to the ED with acute respiratory failure. In addition, the study investigates whether integration of IVC ultrasound with lung ultrasound, bedside cardiac ultrasound, and selected clinical and laboratory variables - such as hemoglobin and plasma protein changes - improves diagnostic performance and prognostic stratification.
Eligibility Criteria
Inclusion Criteria: * Adults aged ≥18 years. * Presentation to the emergency department with acute dyspnea and acute respiratory failure, defined by at least one of the following: * PaO₂ \< 60 mmHg on room air, or * Oxygen saturation (SpO₂) \< 90% on room air, or * PaO₂/FiO₂ ratio \< 300. * Ability to provide written informed consent or eligibility for deferred consent according to local regulations. * Undergoing standard diagnostic evaluation including laboratory tests and chest imaging as part of routine clinical care. Exclusion Criteria: * Refusal to provide informed consent (or consent by legal representative when applicable). * Inadequate ultrasound window or technically insufficient ultrasound assessment. * Acute respiratory failure secondary to chest trauma. * Cardiac arrest at presentation or during emergency department stabilization. * Requirement for invasive mechanical ventilation during initial stabilization in the emergency department.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07324980 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hydrostatic Pulmonary Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07324980 currently recruiting?
Yes, NCT07324980 is actively recruiting participants. Contact the research team at francesco.gavelli@uniupo.it for enrollment information.
Where is the NCT07324980 trial being conducted?
This trial is being conducted at Novara, Italy.
Who is sponsoring the NCT07324980 clinical trial?
NCT07324980 is sponsored by Università degli Studi del Piemonte Orientale Amedeo Avogadro. The trial plans to enroll 200 participants.